Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (hereinafter, the "IVDR") repealing Directive 98/79/EC, entered into force on May 26th, 2017, and applied from May 26th, 2022.

The IVDR lays down rules concerning the placing on the market, making available on the market or putting into service of in vitro diagnostic medical devices for human use and accessories for such devices in the European Union.

Devices are divided into classes A, B, C and D, taking into account their intended purpose and inherent risks; the classification is carried out by the Manufacturer in accordance with Annex VIII of the IVDR.

Before placing on the market or putting in service a device, the Manufacturer shall undertake an assessment of the conformity of that device, in accordance with the applicable procedures set out in Annexes IX to XI of the IVDR.

For devices of classes A sterile, B, C and D, the conformity assessment procedure requires the intervention of a Notified Body, chosen by the Manufacturer.

IMQ as Notified Body for IVDR

IMQ S.p.A. is Notified Body for the Regulation (EU) 2017/746 (IVDR) with publication of the notification in the NANDO system on April 22nd, 2025.

The list of Devices and the relevant conformity assessment procedures for which IMQ is authorized to operate is available on the NANDO system.

The assessment process applied by IMQ S.p.A. is described in the “Regulation for conformity assessment of in vitro diagnostic medical devices pursuant to Regulation (EU) 2017/746 for which IMQ operates as Notified Body No. 0051".

For further information and/or to request a customized quotation from IMQ S.p.A., please contact us by writing to medicali@imq.it

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